Scolaris Content Display Scolaris Content Display

Study flow diagram
Figures and Tables -
Figure 1

Study flow diagram

'Risk of bias' summary: review authors' judgements about each 'Risk of bias' item for each included study
Figures and Tables -
Figure 2

'Risk of bias' summary: review authors' judgements about each 'Risk of bias' item for each included study

Comparison 1 Imiquimod 5% cream with versus without tazarotene 0.1% gel for the treatment of lentigo maligna, Outcome 1 Primary outcome: Histological complete response (ITT).
Figures and Tables -
Analysis 1.1

Comparison 1 Imiquimod 5% cream with versus without tazarotene 0.1% gel for the treatment of lentigo maligna, Outcome 1 Primary outcome: Histological complete response (ITT).

Comparison 1 Imiquimod 5% cream with versus without tazarotene 0.1% gel for the treatment of lentigo maligna, Outcome 2 Primary outcome: Histological complete response (available‐case analysis).
Figures and Tables -
Analysis 1.2

Comparison 1 Imiquimod 5% cream with versus without tazarotene 0.1% gel for the treatment of lentigo maligna, Outcome 2 Primary outcome: Histological complete response (available‐case analysis).

Comparison 1 Imiquimod 5% cream with versus without tazarotene 0.1% gel for the treatment of lentigo maligna, Outcome 3 Secondary outcome: Discontinuation of treatment because of harms.
Figures and Tables -
Analysis 1.3

Comparison 1 Imiquimod 5% cream with versus without tazarotene 0.1% gel for the treatment of lentigo maligna, Outcome 3 Secondary outcome: Discontinuation of treatment because of harms.

Comparison 1 Imiquimod 5% cream with versus without tazarotene 0.1% gel for the treatment of lentigo maligna, Outcome 4 Secondary outcome: Inflammatory response (overall Inflammation score) for participants who finished study.
Figures and Tables -
Analysis 1.4

Comparison 1 Imiquimod 5% cream with versus without tazarotene 0.1% gel for the treatment of lentigo maligna, Outcome 4 Secondary outcome: Inflammatory response (overall Inflammation score) for participants who finished study.

Comparison 1 Imiquimod 5% cream with versus without tazarotene 0.1% gel for the treatment of lentigo maligna, Outcome 5 Secondary outcome: Inflammatory response (overall Inflammation score) for all participants.
Figures and Tables -
Analysis 1.5

Comparison 1 Imiquimod 5% cream with versus without tazarotene 0.1% gel for the treatment of lentigo maligna, Outcome 5 Secondary outcome: Inflammatory response (overall Inflammation score) for all participants.

Comparison 1 Imiquimod 5% cream with versus without tazarotene 0.1% gel for the treatment of lentigo maligna, Outcome 6 Secondary outcome: Inflammatory response (number of lesions with grade 2 or 3).
Figures and Tables -
Analysis 1.6

Comparison 1 Imiquimod 5% cream with versus without tazarotene 0.1% gel for the treatment of lentigo maligna, Outcome 6 Secondary outcome: Inflammatory response (number of lesions with grade 2 or 3).

Summary of findings for the main comparison. Imiquimod 5% cream with tazarotene 0.1% gel compared with Imiquimod 5% cream alone for melanoma in situ, including lentigo maligna

Imiquimod 5% cream with tazarotene 0.1% gel compared with Imiquimod 5% cream alone for melanoma in situ, including lentigo maligna

Patient or population: participants with melanoma in situ, including lentigo maligna
Settings: 1 academic centre in the US
Intervention: imiquimod 5% cream with tazarotene 0.1% gel
Comparison: imiquimod 5% cream alone

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Imiquimod 5% cream alone

Imiquimod 5% cream with tazarotene 0.1% gel

Primary outcome:

Histological complete response (intention‐to‐treat)
No residual LM in staged excision 2 months post‐treatment

587 per 1000

657 per 1000
(475 to 910)

RR 1.12
(0.81 to 1.55)

90
(1 study)

⊕⊕⊝⊝
low¹

Primary outcome:

Histological complete response ( available‐case analysis)
No residual LM in staged excision 2 months post‐treatment

659 per 1000

784 per 1000
(593 to 1000)

RR 1.19
(0.9 to 1.57)

78
(1 study)

⊕⊕⊝⊝
low¹

Secondary outcome:

Discontinuation of treatment because of harms
Discontinuation of treatment due to adverse effects

22 per 1000

136 per 1000
(17 to 1000)

RR 6.27
(0.79 to 50.02)

90
(1 study)

⊕⊕⊝⊝
low¹

Secondary outcome:

Inflammatory response (number of lesions with grade 2 or 3)
Grade 2 or 3 Inflammation²

591 per 1000

815 per 1000
(615 to 1000)

RR 1.38
(1.04 to 1.84)

88
(1 study)

⊕⊕⊝⊝
low¹

Secondary outcome:

Inflammatory response

(overall Inflammation score) for all participants
Mean grade of inflammation in each group²

The mean overall inflammation score (inflammatory response) for all participants in the intervention groups was 0.60 higher
(0.2 to 1 higher)

88
(1 study)

⊕⊕⊝⊝
low¹

*The basis for the assumed risk (e.g., the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

GRADE = Grading of Recommendations Assessment, Development and Evaluation.
LM = lentigo maligna.
¹Published evidence is limited to a single randomised trial.
²(0 indicates no inflammation; 1, pink; 2, red; and 3, the presence of erosions, oozing, or eschar).

Figures and Tables -
Summary of findings for the main comparison. Imiquimod 5% cream with tazarotene 0.1% gel compared with Imiquimod 5% cream alone for melanoma in situ, including lentigo maligna
Table 1. Glossary of medical terms

Medical term

Explanation

Intraepidermal

something confined within the epidermis

Preinvasive

a malignant tumour that remains constricted in the epithelium, while the dermo‐epidermal junction preserves its integrity

Eschar

a dry scab or slough formed on the skin as a result of a burn or by the action of a corrosive or caustic substance

Invasive

a malignant tumour that breaks the dermo‐epidermal junction and invades the dermis

Lentigo maligna

a subtype of preinvasive intraepidermal melanoma, associated specifically with chronic solar exposure

Vehicle

an excipient or a menstruum, a substance, usually without therapeutic action, used as a medium to give bulk for the administration of medicines

Apoptosis

a genetically directed process of cell self‐destruction that is marked by the fragmentation of nuclear DNA. It is activated either by the presence of a stimulus or removal of a suppressing agent or stimulus, and is a normal physiological process eliminating DNA‐damaged, superfluous, or unwanted cells. It is a synonym for programmed cell death

Actinic keratosis

rough, scaly macule or patch of skin that it is considered precancerous and is associated with chronic sun exposure

Lentigo senilis

a flat brownish, pigmented spot on the skin, due to increased deposition of melanin and an increased number of melanocytes

Seborrheic keratosis

a benign skin tumour that occurs singly or in clusters on the surface of the skin, is usually light to dark brown or black in colour, and typically has a warty texture often with a waxy appearance

Patch

a greater than 1 cm circumscribed area of discolouration on the skin

Cytokine

a small protein released by cells that has a specific effect on the interactions between cells, on communications between cells, or on the behavior of cells

Innate immunity

immunity that occurs naturally as a result of a person's genetic constitution or physiology and does not arise from a previous infection or vaccination

Blinding

the concealment of group assignment ‐ to either the treatment or control group ‐ from the knowledge of participants, investigators in a clinical trial, or both

Tumour islands

aggregates of tumour cells

Figures and Tables -
Table 1. Glossary of medical terms
Comparison 1. Imiquimod 5% cream with versus without tazarotene 0.1% gel for the treatment of lentigo maligna

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Primary outcome: Histological complete response (ITT) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2 Primary outcome: Histological complete response (available‐case analysis) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3 Secondary outcome: Discontinuation of treatment because of harms Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

4 Secondary outcome: Inflammatory response (overall Inflammation score) for participants who finished study Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

5 Secondary outcome: Inflammatory response (overall Inflammation score) for all participants Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

6 Secondary outcome: Inflammatory response (number of lesions with grade 2 or 3) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Figures and Tables -
Comparison 1. Imiquimod 5% cream with versus without tazarotene 0.1% gel for the treatment of lentigo maligna